Onco-Innovations Commences Activities to Manufacture Nanoparticle Formulation with Dalton Pharma to Supply Preclinical Animal Studies

Rhea-AI Summary

Onco-Innovations (OTCQB:ONNVF) has initiated manufacturing activities with Dalton Pharma Services for its proprietary nanoparticle formulation, PEO-b-PBz-CL. This formulation is a crucial component of Onco's drug delivery platform designed to work with their PNKP inhibitor.

The manufacturing process will involve scale-up activities from 10 grams to 350 grams, focusing on optimization and establishing reproducible synthesis methods. Dalton will ensure the formulation meets quality specifications for purity, molecular weight, and residual solvent levels, while generating necessary analytical data for regulatory filings and future GMP manufacturing.

Positive

• Partnership with Dalton Pharma Services, a leading Canadian contract development and manufacturing organization
• Successful initial feasibility demonstration at 10 grams scale
• Planned scale-up to 350 grams production capacity
• Development package will include comprehensive analytical characterization and process documentation

Negative

• Product still in early preclinical stage, far from commercialization
• Need to reduce residual catalyst content indicates current manufacturing challenges

VANCOUVER, BC / ACCESS Newswire / September 19, 2025 / Onco-Innovations Limited (CBOE CA:ONCO )(OTCQB:ONNVF )(Frankfurt:W1H) (WKN: A3EKSZ ) (" Onco " or the " Company ") is pleased to announce that Dalton Pharma Services ("Dalton") has commenced activities to manufacture Onco's proprietary nanoparticle formulation, also know as PEO-b-PBz-CL ¹ , a key component of the Company's novel drug delivery platform which is designed for use in conjunction with Onco's proprietary Polynucleotide Kinase Phosphatase (PNKP) inhibitor. The manufacturing initiative is intended to generate the nanoparticle material required to advance preclinical studies.

The production campaign will include process optimization and scale-up activities to establish reproducible methods for the synthesis of PEO-b-PBz-CL, while ensuring that the formulation meets quality specifications for purity, molecular weight, and residual solvent levels. Dalton has already demonstrated initial feasibility at the 10 grams scale and will now focus on reducing residual catalyst content and scaling production to 100 grams, followed by a demonstration batch at the 350 grams scale. These activities are designed to provide sufficient quantities of nanoparticle material for formulation development, while also generating the analytical data necessary to support regulatory filings and the eventual transition to Good Manufacturing Practice (GMP) manufacturing.

By engaging Dalton, Onco benefits from the technical expertise and regulatory experience of one of Canada's leading contract development and manufacturing organizations. Dalton's work will provide a comprehensive development package, including full analytical characterization and process documentation, to ensure a smooth path toward clinical readiness of the nanoparticle-formulated platform.

" Advancing the nanoparticle formulation demonstrates will help inform our next phase of development, advancing our pathway toward the clinical opportunities we are determined to reach, " stated Thomas O'Shaughnessy, CEO of Onco-Innovations.

About Onco-Innovations Limited

Onco-Innovations is a Canadian-based company dedicated to cancer research and treatment, specializing in oncology. Onco's mission is to pursue the prevention and treatment of cancer through pioneering research and innovative solutions. The company has secured an exclusive worldwide license to patented technology that targets solid tumours.

ON BEHALF OF ONCO-INNOVATIONS LIMITED,

" Thomas O'Shaughnessy "
Chief Executive Officer

For more information, please contact:

Thomas O'Shaughnessy
Chief Executive Officer
Tel: + 1 888 261 8055
investors@oncoinnovations.com

Forward-Looking Statements Caution. This news release contains forward-looking statements, including in relation to the benefits expected to be realized under the agreement with Dalton, and the Company's ability to move forward with its plans for manufacturing and further testing and development of its Technologies, the prospects of the Company, and the Company's business and plans generally, and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "potential", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

¹poly(ethylene oxide)-block-poly(α-benzyl carboxylate ε-caprolactone)

SOURCE: Onco-Innovations Limited

View the original press release on ACCESS Newswire

FAQ

What is the purpose of Onco-Innovations' partnership with Dalton Pharma Services?

Dalton will manufacture Onco's proprietary nanoparticle formulation (PEO-b-PBz-CL) to supply preclinical animal studies and establish reproducible manufacturing methods.

What are the key manufacturing scale-up targets for ONNVF's nanoparticle formulation?

The manufacturing will scale up from 10 grams to 100 grams, followed by a demonstration batch at 350 grams.

What is PEO-b-PBz-CL and how is it used by Onco-Innovations?

PEO-b-PBz-CL is a proprietary nanoparticle formulation that serves as a key component of Onco's novel drug delivery platform, designed to work with their PNKP inhibitor.

What quality specifications will Dalton ensure for ONNVF's nanoparticle formulation?

Dalton will ensure the formulation meets specifications for purity, molecular weight, residual solvent levels, and will reduce residual catalyst content.

How will this manufacturing initiative support Onco-Innovations' regulatory pathway?

The initiative will generate analytical data and comprehensive documentation necessary for regulatory filings and future transition to Good Manufacturing Practice (GMP) manufacturing.